FloraSeq LLC's 'poop pill' not for the squeamish

Steve Visuri (left) and Karen Harrington are partners in FloraSeq LLC, a Waukesha company that is developing a pill from human stool to cure guts in which bad bacteria has taken over. Credit: Michael McLoone

The main ingredient in a pill being developed by FloraSeq LLC will undoubtedly put patients off.

But if FloraSeq's founders are correct, and the pill cures a stubborn and prevalent hospital-acquired infection, patients are likely to get past the ingredient — human feces.

"There's a popular misconception that all stool is teeming with harmful bacteria such as E. coli or salmonella, which can cause large outbreaks of illness, but that is seldom true," said Steve Visuri, co-founder, president and chief executive officer of the Waukesha start-up. "While we don't recommend people routinely ingest stool, carefully screened stool from healthy individuals is actually filled with an exceptional amount of beneficial bacteria that can be used to cure patients with intestinal infections."

The bottom line: FloraSeq is developing a pill to be ingested orally that is teeming with good bacteria from other people's stool samples.

The human gut is home to as many as 100 trillion microorganisms, representing about 400 known bacterial species, Visuri said. In the past few years, scientist have become increasingly interested in those bacteria, whose genes are collectively referred to as the human microbiome.

"One of the hottest areas of research right now is microbiomes," said Lisa Johnson, chief executive officer of BioForward, the trade organization for Wisconsin's bioscience industry.

Researchers have been finding connections between bacteria in the gut and diabetes, lupus and other autoimmune diseases and other conditions, Johnson said. The problem FloraSeq is trying to fix often occurs after long-term use of antibiotics wipes out the good bacteria and allows the bad bacteria to grow out of control.

Among the worst culprits is the C. difficile bacterium, which can cause horrible diarrhea, abdominal pain and other symptoms, said Dan Stein, a physician and director of the Inflammatory Bowel Disease Program at Froedtert Hospital.

Antibiotics are the standard treatment for C. difficile infections, but they don't work in 15% to 20% of patients, Stein said. Fecal transplants — where a healthy donor's stool is transferred into the patient's gastrointestinal tract through colonoscopy, endoscopy or other invasive procedures — have grown in popularity during the past five years as the next option and have a 90% to 95% cure rate, he said.

FloraSeq's pill would theoretically have the same effectiveness as a fecal transplant, but with a more palatable delivery method.

"The reality is that about 200,000 patients a year fail antibiotics and live absolutely miserable lives for months or years, and 30,000 of them succumb to their illness," Visuri said. "These are the desperate patients we're focused on helping with our poop pills."

The pill, which has no smell and no taste, may take as many as four years to get to market, Visuri said. But there are many reasons its path to commercialization looks promising.

There is a large potential market for the pill, said Todd Sobotka, investment manager at BrightStar Wisconsin.

BrightStar recently invested $50,000 in FloraSeq to help the start-up prove the feasibility of its idea; it was the first time that the foundation was the sole investor in a deal, Sobotka said.

FloraSeq should be on a fast track for regulatory approval because the underlying therapy has been proven with fecal transplants, he said. And Visuri and his partner, Karen Harrington, are known to several BrightStar officials.

Visuri and Harrington worked at Prodesse Inc. and companies that acquired it. Tom Shannon, BrightStar's top executive, led Prodesse to a sale in 2009 to Gen-Probe Inc. While at Prodesse, Visuri and Harrington were part of the team that created a test for diagnosing the C. difficile bacterium.

FloraSeq, which formed in September 2014, is working to develop a patent portfolio around its methods and manufacture of materials and donor selection, Visuri said. For raw materials, the start-up relies on friends and family — they're screened in a similar way to blood donors — to provide donations.

To make the pills, FloraSeq scientists process the donated stool samples to isolate the bacteria — it currently has the dose down to eight pills, Visuri said.

"That's probably our biggest technical challenge; to maintain the viability of the bacteria and concentrate them down," he said.

Study of the human microbiome — all of the microorganisms that live on our skin and in our bodies — is a hot topic in science and is increasingly translating into commercial products. One competitor to FloraSeq's pill is Seres Therapeutics in Boston.

Seres is well-funded and a year or two ahead of FloraSeq, so the Wisconsin start-up "has some catching up to do," Visuri said. But Seres is intentionally killing off many of the bacteria, while FloraSeq is taking the opposite approach, he said.

Scientists don't really have a good sense of what a healthy gut looks like, but they know that the more diverse the bacteria, the better, Visuri said.

"What we're aiming to do is to re-establish a wide variety of the gut bacteria," he said.

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TIPS FOR A HEALTHY GUT

The human gut contains 10 times more bacteria than all the human cells in the entire body, said Steve Visuri, FloraSeq LLC's founder, president and chief executive officer. "In fact, you could say that we're more bacterial than we are human," Visuri said. "So we should not only focus on feeding ourselves, but on feeding our bacteria." Here are Visuri's tips for maintaining a healthy gut: